CN103720529B

CN103720529B - Arcus aortae intraoperative stent and method for manufacturing stent

Info

Publication number: CN103720529B
Application number: CN201310745529.1A
Authority: CN
Inventors: 王永胜; 徐志云; 张德元
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2013-12-30
Filing date: 2013-12-30
Publication date: 2017-02-08
Anticipated expiration: 2033-12-30
Also published as: WO2015101292A1; US20160310258A1; CN103720529A; CN105873543A; EP3090707A1; US10548709B2; EP3090707A4; CN105873543B

Abstract

The invention provides an arcus aortae intraoperative stent which comprises a main body and one to three branches. The arcus aortae intraoperative stent enables a plurality of annular wave-shaped stents to be connected through a tectorial membrane to form the main body and the branches, each annular wave-shaped stent comprises an elastic wire, and the heads and tails of the elastic wires are connected to form an annular shape. A method for manufacturing the arcus aortae intraoperative stent comprises the following steps of providing a tectorial membrane mold, manufacturing an inner layer membrane, assembling the annular wave-shaped stents, manufacturing an outer layer membrane, sewing proximal fabrics and sewing distal fabrics. The arcus aortae intraoperative stent can automatically adapt to blood vessel structures nearby arcus aortae of different patients, the main body in the arcus aortae intraoperative stent has enough radial supporting force on the branches, it is guaranteed that the branches of the arcus aortae intraoperative stent can safely enter branch blood vessels in an operation, and meanwhile the phenomenon that in the operation and after the operation, the branches slip from the corresponding branch blood vessels is avoided.

Description

Arch of aorta art medium-height trestle and the manufacture method of this support

Technical field

The invention belongs to medical instruments field, in more particularly, to a kind of art for human aortic bow hybridization operative treatment Support and the manufacture method of this support.

Background technology

Dissection of aorta refers to, due to inner membrance local laceration, be impacted by strong blood, inner membrance phased separation, expansion Exhibition, forms true, false two chambeies in intra-arterial.According to Stanford classifying method, dissection of aorta is divided into A type and two kinds of Type B：A type Dissection of aorta refers to that intimal tear is located at aorta ascendens, the arch of aorta or proximal segment descending aorta, extension involve aorta ascendens or Aortic arch, also can extend to descending aorta or even abdominal aorta；Type B dissection of aorta refers to that intimal tear is located at aortic isthmus Portion, extension is only involved descending aorta or is extended to abdominal aorta, but does not involve aorta ascendens and the arch of aorta.According to epidemiology Data, the annual morbidity of dissection of aorta is A type dissection of aorta for 5/,100,000, wherein 2/3.Calculate according to this, China is new every year Send out dissection of aorta case about 75000 people, wherein A type dissection of aorta is about 50000 people.Wherein acute Stanford A type master Artery dissection（Acute aortic dissection type A, abbreviation AADA）It is that department of cardiovascular surgery field is most commonly seen and For dangerous sustainer acute disease.If untreated, the death rate of AADA morbidity one week after is up to 50-91%；If only receiving internal medicine to protect Keep treatment, the death rate reaches 20% within 24 hours, and the death rate is up to 30% within 48 hours.Therefore, AADA mono- after diagnosing, if no operation taboo Disease is it is necessary to emergency surgery intervention.Even if but under the conditions of modern medical service, perioperative deaths rate is also up to 15-35%.

At present, the treatment for A type dissection of aorta mainly has two class modus operandis, i.e. traditional open surgery With new hybridization operation.In terms of open surgery, nineteen eighty-three Borst etc. proposes " trunk " technology（elephant trunk technique）.For the patient of A type dissection of aorta, " trunk " technology typically requires a point I stage operation, II stage operation Carry out, I stage operation is repaired to aortic arch, II stage operation can be repaired to descending aorta.In I stage operation, need Will be through arch of aorta fall portion otch by one section of artificial terylene Vascular implantation descending aorta, near-end is fixed, far-end is spacious put it is therefore an objective to Create conditions for descending aorta at a specified future date operation, simplify the operation of II stage operation, reduce operation risk.The problem that " trunk " technology exists Be to oppressed by false chamber the true chamber of very little is implanted into relatively soft artificial terylene blood vessel, difficult in operation, sometimes Even can not complete；And patient is during waiting II stage operation, there is the possibility forming dissecting aneurysm in descending aorta, or even Lethal risk summation is ruptured at a relatively high during having the lethal risk of rupture, I stage operation, II stage operation and two operations（Usually More than 20%）, some patients refuse II stage operation because the reason such as fearing, and between suitable between two operations the phase is not yet Finally give generally acknowledged.If descending aorta expansion between two operations, " trunk " artificial terylene blood vessel is by " floating " in fall actively In arteries and veins, exist and fold distortion and form the risk that lateral thrombus even comes off, soft artificial terylene blood vessel is to native blood vessel wall No supporting role is it is impossible to promote false chamber thrombosis and reconstruct.And this operation is very big to the wound of patient, operating difficulty is big, Operating time is long, and intraoperative blood loss is big.

1999, a technology with milestone significance ----aorta pectoralis EVAR（Thoracic Endovascular aortic repair, abbreviation TEVAR）By California, USA stanford University Medical College The scholars such as Dake are initially applied to the clinical treatment of Type B dissection of aorta.One section of covered stnet blood vessel of this technology application, by spy Different push and release system, drive in the wrong direction through femoral artery and deliver to descending aorta near-end（Left subclavian artery far-end）.This technology can Blood flow is completely cut off with lesion locations, and true chamber can be expanded and promote false chamber closure.This technology wound is little, when patient recovers Between fast, good effect is confirmed by the Follow-up results more than 10 years.In aortic arch, also someone should in research at present Treated with the method for simple chamber intervenien therapy.Special yet with the complicated anatomy of the arch of aorta and haemodynamics Levy, for current TEVAR technology, existing simple chamber intervenien therapy scheme is primarily directed to aortic arch subregion PCI, and complex operation, be also not reaching to popularization and application in practice, so at present the arch of aorta is extended to pathology The A type dissection of aorta in portion is irrealizable using completely intracavitary therapy.

In order to reduce the difficulty that above-mentioned " trunk " technology is applied in descending aorta, medical expert is had to propose comprehensive biography System surgical operation and Endovascular prosthesis technical characterstic hybridization operation and in the treatment of A type dissection of aorta Obtain successfully and promote.For example disclose art medium-height trestle in U.S. Patent application US2010/0042201A1 and add the arch of aorta and replace Hand-off art, the cardinal principle of this hybridization operation is：Method first with surgical operation discharges one not in descending aorta With the art medium-height trestle of branch, this art medium-height trestle relies on the radial support power of itself can be fixed on descending aorta section, may also function as Expand the effect in true chamber, then substitute the lesion vesselses of aortic arch with artificial blood vessel, the distal suture of artificial blood vessel is in art The near-end of medium-height trestle, and each previous anastomotic with human vas is coincide.This operation method makes most patient avoid Second operation, eliminates the wound in second operation, patient being caused.But still need outside tradition at arch of aorta position The method of section's surgery excision, most patient needs five previous anastomotic, and operating difficulty is still very big to a lot of doctors, surgical procedure Amount of bleeding higher, once the bleeding simultaneously of multiple previous anastomotic, then judge blutpunkte and to stop blooding be an extremely difficult job, And postoperative there is also certain complication.

Therefore at present for A type dissection of aorta, clinically still mainly adopt the treatment of surgical operation or hybridization operation Method, hybridization operation is compared traditional surgery and is had been obtained for simplified partial, but how to simplify operation technique, contracting further Short time, reduce intraoperative blood loss, and shorten the time that brain blood interrupts, be the problem of the previous main exploration of mesh.Actively Arcus haemalis portion anatomical structure is complicated, and operation vascular anastomosis mouth is more to be to lead to complicated and time length main cause of performing the operation, therefore The quantity reducing previous anastomotic by the method discharging support is current key tactics.It is thus desirable to a meet the arch of aorta The band branch stent of anatomic form, but it is because that human aortic bends the particularity of anatomical structure, it and three branch vessel phases Even, respectively left subclavian artery, LCC, innominate artery, these three branch vessel to upper limbs and brain just ensure Often blood supply, and the spacing distance of these three branch vessel varies with each individual, the difficult point of operation is that three branches of art medium-height trestle will Be capable of safety enters in corresponding branch vessel, in surgical procedure and postoperative branch will not be shifted over and slip, false If the branch in art medium-height trestle shifts from branch vessel even departing from, will result in serious consequence.

Content of the invention

It is an object of the invention to provide a kind of arch of aorta art medium-height trestle, it is pointed to for by way of being performed the operation by hybridization The A type dissection of aorta disease of aortic arch is treated it is intended to be figured out how to develop a safe and reliable arch of aorta Art medium-height trestle, the blood vessel structure near the arch of aorta of the different patients of adaptation is it is ensured that this art medium-height trestle is permissible in operation automatically Safety be implanted to arch of aorta main body and each branch vessel, and each position of this art medium-height trestle after surgery will not occur The problems such as displacement, interior leakage.

The present invention is achieved in that a kind of arch of aorta art medium-height trestle, has elasticity and can be compressed, including in a tubular form Main body and one to three branch in a tubular form, have and be linked to be one on the tube wall of described main body and on the tube wall of described branch The overlay film of body, described main body proximally and distally respectively there is one first opening, described main body include bend section and fall principal piece, described Branch is all arranged in the same side of bow section, the same side of described bow section have equal with the quantity of described branch and with each The interface that the first end of described branch connects, each described interface forms a closure line of demarcation, Mei Yisuo on described overlay film Second end relative with its first end stating branch has one second opening, and described fall principal piece includes at least one first ring-type ripple Shape support, described bow section includes the second ring waveform support equal with the quantity of described branch, and each described branch includes At least one the 3rd ring waveform support, branches into first from described in nearest one of near-end of described arch of aorta art medium-height trestle Branch, the part bow section between described near-end and described first branch includes a second ring waveform support, described Overlay film is by all of described first ring waveform support, described second ring waveform support and described 3rd ring waveform support even It is connected into one.

Further, multiple first ring waveforms that described fall principal piece includes arranging along the axially spaced-apart of described main body prop up Frame, is connected with head rod between the plurality of first ring waveform support, described head rod for linear pattern and with institute State branch the same side in described main body.

Or, the diameter of all described first ring waveform supports is equal or in described near-end to described far-end Successively decrease on direction.

Or, include spaced multiple 3rd ring waveform from a nearest described branch of described fall principal piece and prop up Frame, arranges a second L-shaped connecting rod, the length of described second connecting rod in the side of the close described fall principal piece of this branch Multiple 3rd ring waveform supports in this branch are linked together by arm, and the galianconism of described second connecting rod is fixed on described In one connecting rod or on a nearest first ring waveform support of this branch.

Further, each described branch the second ring waveform support described in supports respectively, this second ring Described closure line of demarcation corresponding to around respective branch for the waveform on shape waveform support.

Or, each described branch includes spaced multiple 3rd ring waveform support, in each described branch Also set up a second L-shaped connecting rod or linear 3rd connecting rod, described second connecting rod long-armed or Multiple 3rd ring waveform supports in one branch are linked together by the 3rd connecting rod described in person, described second connection The galianconism of bar is fixed on the second ring waveform support supporting one branch, and described second connecting rod is located at described branch The near-end of close described main body side.

Or, formation V-arrangement line of demarcation on overlay film around described closure accordingly is marginal for the described waveform, described close Close line of demarcation and embed what that a part of depth in the area defined of described V-type line of demarcation and this V-type line of demarcation were surrounded The ratio of the height in region is at least 1:2, or, the marginal at least half area of described closure is located at described V-type line of demarcation institute In the region surrounding.

Further, near the 3rd ring waveform support described in of described first end and the described bow of each described branch The distance between section scope is 4mm-10mm.

Further, in the described 3rd ring waveform support of each described bifurcation, near described the of this branch Minimum and this waveform the quantity of the height of the waveform of one described 3rd ring waveform support at two ends is most.

Further, near the diameter of a described 3rd ring waveform support at described second end of each described branch Described first end along this branch is gradually reduced to the direction at described second end and makes the described the second end of this branch in necking Shape.

Further, near the diameter of a described 3rd ring waveform support of described first end of each described branch It is gradually reduced to the direction of described first end along described second end of this branch and make the described first end of this branch in necking Shape.

Further, the material of described overlay film is expanded PTFE, and described overlay film includes inner layer film and outer membrane, institute State inner layer film and outer membrane combines so that all described ring waveform supports to be wrapped between inner layer film and outer membrane.

Further, the material of described overlay film is woven dacron, and all described ring waveform supports are sewn to described overlay film The outside of tube wall or inner side.

Further, part bow section only one of which the second ring-type ripple between described near-end and described first branch Shape support, each section bow section also only one of which the second ring waveform support between two neighboring branch.

Further, the near-end of described main body is provided with near-end fabric in a tubular form, described near-end fabric and described overlay film It is connected, the first paragraph of described near-end fabric is separated with described second ring waveform support, the first paragraph of described near-end fabric With second segment be fixed on described second ring waveform support, the diameter of the first paragraph of described near-end fabric is knitted than described near-end The diameter of the second segment of thing is little；The far-end of described main body is provided with far-end fabric in a tubular form, and described far-end fabric is covered with described Film is connected, and is fixed on described first ring waveform support, described far-end fabric align with the end face of described far-end or Described in person, far-end fabric stretches out outside described far-end.

Another object of the present invention is to providing a kind of manufacture method of arch of aorta art medium-height trestle, comprise the steps：

S1）There is provided an overlay film mould, described overlay film mould includes the first cylinder and is connected on described first cylinder Two cylinders, described first cylinder is divided into the first shell of column and the second shell of column, the quantity of described second cylinder and described arch of aorta art The numbers of branches of medium-height trestle is identical, and described second cylinder is connected on the same side of described second shell of column；

S2）Inner layer film in the outer surface described overlay film of making of described overlay film mould；

S3）There is provided some described ring waveform supports, all first ring waveform spacer support frames are placed on described first shell of column On, each described second ring waveform support is placed on described second shell of column and is spaced apart described second cylinder, at least one Second ring waveform support is located between the near-end of the first cylinder and the second cylinder, each second cylinder mate at least one the Two ring waveform supports, and making wherein one waveform of this second ring waveform support, to be stuck in this second ring waveform support corresponding On described second cylinder, described 3rd ring waveform spacer support frame is placed on every one second cylinder；

S4）Described ring waveform support is sewn on described inner layer film, using inner layer film as overlay film；Or, in institute The outer surface stating overlay film mould makes the outer membrane of described overlay film, and so that described outer membrane is combined with described inner layer film and wrap up institute State ring waveform support.

Further, the manufacture method of arch of aorta art medium-height trestle, also comprises the steps：

S5）Near described near-end a described second ring waveform support be arranged on this second ring waveform support Overlay film suture a near-end fabric in a tubular form, described near-end fabric has and this detached first paragraph of the second ring waveform support And the second segment with the suture of this second ring waveform support, the diameter of described first paragraph is less than the diameter of described second segment；

S6）At least a portion the first ring waveform support in described some first ring waveform supports be arranged at these The overlay film of the first ring waveform support sutures a far-end fabric in a tubular form, and described far-end fabric is alignd with the end face of described far-end Or described far-end fabric stretches out outside described far-end.

S2）There is provided some described ring waveform supports, all first ring waveform spacer support frames are placed on described first shell of column On, each described second ring waveform support is placed on described second shell of column and is spaced apart described second cylinder, at least one Second ring waveform support is located between the near-end of the first cylinder and the second cylinder, each second cylinder mate at least one the Two ring waveform supports, and making wherein one waveform of this second ring waveform support, to be stuck in this second ring waveform support corresponding On described second cylinder, described 3rd ring waveform spacer support frame is placed on every one second cylinder；

S3）The sheathed described overlay film of outer surface in described ring waveform support；

S4）By described overlay film and described ring waveform support suture.

The present invention having the technical effect that with respect to prior art：The arch of aorta art medium-height trestle that the present invention provides can be automatic Adapt to the blood vessel structure near the arch of aorta of different patients, and the main body in arch of aorta art medium-height trestle keeps foot to branch Enough radial support power it is ensured that branch on arch of aorta art medium-height trestle in operation be capable of safety enter into branch vessel Interior, simultaneously in operation and postoperative avoid branch to slip out from corresponding branch vessel.The sustainer that the present invention provides Bow art medium-height trestle has advantages below：

1）Heretofore described arch of aorta art medium-height trestle, main body provides reliable support force to branch, so may be used To ensure that branch completely in branch vessel, and can avoid the stent migration of long-term postoperative to slip.

2）Because arch of aorta anatomical structure is complicated, the individual difference of the spacing of three branch vessel of different patients compares Greatly.And the A type dissection of aorta disease of aortic arch is usually emergency treatment, the time therefore not having abundance is patient's customization and trouble The specialities of the arch of aorta branch spacing coupling completely of person.Heretofore described arch of aorta art medium-height trestle, branch it Between spacing Automatic adjusument can be carried out according to the anatomic form of the arch of aorta, solve patient sustainer arch state individual difference Ratio is larger, is difficult to the problem of coupling arch of aorta art medium-height trestle in emergency operation.

3）Heretofore described arch of aorta art medium-height trestle, main body and branch can be using overall ectonexines ePTFE（Expanded PTFE）Film bilayer film coating technique, the inner wall smooth of branch, reduce the formation of thrombus, to brain blood Pipe forms good protective effect.Between branch and main body, no suture is connected, no the risk of blood leakage.Can be attached in main body Plus near-end fabric, for example, it is sewed with the woven dacron of one section of tubulose in the near-end of main body, this section of some region of woven dacron near-end does not have There is metallic support to support, and this part of woven dacron diameter is slightly less than main body and has metallic support to bend the diameter of section part, washs Synthetic fibre cloth be ensure that and reliably coincide with blood vessel, the smaller appearance that turn avoid with woven dacron fold during vascular anastomosis of its diameter.This Outward, main body can be with additional remote fabric, for example, and the far-end seam of main body can also be sewed with the woven dacron of one section of tubulose, this section The a bit of region of far-end of woven dacron also can be without metallic support and supports, and this section of woven dacron ensure that the far-end of main body has reliability Sewing properties, guarantee is provided for possible surgical treatment at a specified future date.

4）The fall principal piece of the heretofore described main body of arch of aorta art medium-height trestle can adopt taper, preferably adapts to The anatomic form of descending aorta.

5）One loop waveform support of the heretofore described top of branch of arch of aorta art medium-height trestle adopts The design of small form solid matter is it is ensured that the good adherent performance in branch top.

6）One loop waveform support of the heretofore described top of branch of arch of aorta art medium-height trestle adopts Shrink mouth shape（Top diameter is minimum）, remaining waveform adopts Straight, so both ensure that branch in arch of aorta branch vessel Interior stability, turn avoid and damage branch vessel because of the top of branch to the overdistension power of branch vessel.

7）One loop waveform support of the lowermost end of each branch of arch of aorta art medium-height trestle of the present invention is Shrink mouth shape（Minimum near the diameter of body side）, this design can ensure that branch can preferably be freely swung, from And preferably adapt to the arch of aorta of different patients and the anatomic form difference of branch vessel.

Brief description

Fig. 1 is the schematic appearance of the arch of aorta art medium-height trestle that the present invention provides；

Fig. 2 is that the arch of aorta art medium-height trestle of Fig. 1 is implanted to structure and the view of aortic arch；

Fig. 3 is the front view of the metallic support of application in the arch of aorta art medium-height trestle that first embodiment of the invention provides；

Fig. 4 is the branch and second ring-type ripple corresponding with this branch applying in the arch of aorta art medium-height trestle of Fig. 3 The front view of shape support；

Fig. 5 is the top view of Fig. 3；

Fig. 6 is that the metallic support of Fig. 3 is coated with the front view after inner layer film；

Fig. 7 is that the metallic support of Fig. 3 is coated with the front view after inner layer film and outer membrane；

Fig. 8 is the front view of the arch of aorta art medium-height trestle that first embodiment of the invention provides, and illustrates woven dacron in far-end The first kind of way of arrangement；

Fig. 9 is the front view of the arch of aorta art medium-height trestle that first embodiment of the invention provides, and illustrates woven dacron in far-end The second way of arrangement；

Figure 10 is the front view of the metallic support of application in the arch of aorta art medium-height trestle that second embodiment of the invention provides；

Figure 11 is the front view of the metallic support of application in the arch of aorta art medium-height trestle that third embodiment of the invention provides；

Figure 12 is the front view of the metallic support of application in the arch of aorta art medium-height trestle that fourth embodiment of the invention provides；

Figure 13 be in arch of aorta art medium-height trestle manufacture method provided in an embodiment of the present invention application overlay film mould just View；

Figure 14 is the block diagram of the arch of aorta art medium-height trestle manufacture method that first embodiment of the invention provides；

Figure 15 is the block diagram of the arch of aorta art medium-height trestle manufacture method that second embodiment of the invention provides；

Figure 16 is the block diagram of the arch of aorta art medium-height trestle manufacture method that third embodiment of the invention provides.

Specific embodiment

In order that the objects, technical solutions and advantages of the present invention become more apparent, below in conjunction with drawings and Examples, right The present invention is further elaborated.It should be appreciated that specific embodiment described herein is only in order to explain the present invention, and It is not used in the restriction present invention.

Refer to Fig. 1, Fig. 5, Fig. 7, the unitary construction of the arch of aorta art medium-height trestle that first embodiment of the invention provides sets Count into the structure being consistent with aortic arch form, including a main body 17 and at least one branch 5,6,7, according to pathology Involve situation, this arch of aorta art medium-height trestle may be selected to be provided with one to three branch.Arch of aorta art medium-height trestle props up for overlay film Frame, the tubulose that is, main body 17 and branch 5,6,7 are all made up of the overlay film 25 of compressible metallic support and metal support surface Structure.Respectively there is at the near-end 22 of described main body 17 and at far-end 23 one first opening 17a, described main body 17 is in its overlay film 25 Side is connected with first end a of each described branch respectively by interface 14,15,16, each described branch with described first The second relative end b of end a has one second opening 4.

The metallic support of main body 17 and branch is all axially to be rearranged by multi-turn ring waveform support, main body 17 On ring waveform support be substantially vertical with the arragement direction of the ring waveform support in branch.Each described ring waveform Support includes the end to end elastic yarn forming ring-type, and described elastic yarn is all attached on the tube wall of overlay film 25.Each described ring Shape waveform support has symmetrical central shaft, described elastic yarn has around this symmetrical centre axle distribution and axially projection be in Ring-type and be in wavy some waveforms in radially projecting.Axis projection annularly refers to described elastic yarn along described ring waveform The axis of support makees projection annularly, and radially projecting refers to described elastic yarn along the radial direction of described ring waveform support in wavy Make projection in wavy.Described some ring waveform supports are divided into several the first ring waveform supports 31 and described interface（14、 15、16）The second equal ring waveform support of quantity（1、2、3）And it is located at each described bifurcation and the extension side along this branch To several the 3rd ring waveform supports 33 spaced.Several the first ring waveform supports 31 described are adjacent and along described The bearing of trend of main body is spaced as first group of fall principal piece 172 being distributed in described main body, all described second ring-type ripples Shape support 1,2,3 is adjacent and bearing of trend of along described main body is spaced as second group of bow section being distributed in described main body 17.

Main body 17 includes the smooth bow section 171 linking into an integrated entity and fall principal piece 172 by overlay film 25, bends section 171 It is discharged into arch of aorta position, fall principal piece 172 is discharged in descending aorta.The near-end 22 of main body 17 is in bow section 171 and close Heart, the far-end 23 of main body 17 is in fall principal piece 172 and away from heart.Described branch（5、6、7）, described interface（14、15、16）All With described second ring waveform support（1、2、3）Correspond.Each described interface on overlay film 25 has generally circular Closure line of demarcation c, second ring waveform support corresponding with this interface has the closure line of demarcation c of one section of waveform 8 and this interface Between closest, this waveform 8 forms V-type line of demarcation d on overlay film 25, and described closure line of demarcation c embeds described V-type line of demarcation In d area defined.The A/F L3 of V-type line of demarcation d can be more than the maximum outside diameter of closure line of demarcation c, so that closing At least half area within the c of line of demarcation is located in the d area defined of V-type line of demarcation.The A/F L3 of V-type line of demarcation d The maximum outside diameter of closure line of demarcation c can also be equal to or slightly less than, the sub-fraction of closure line of demarcation c inner area can embed institute State in the d area defined of V-type line of demarcation.As more common embodiment, in the corresponding main body in the lower section of each branch 17 Position be provided with least one second ring waveform support, and have one on wherein at least one the second ring waveform support Waveform 8 bypasses near the egress edge that the first end a phase of corresponding branch is formed.Fig. 5 is the partial top view of main body 17, is Clearly show interface 14 on described overlay film with a kind of wherein embodiment of the second ring waveform support 1 relative Position, in figure omits overlay film, in fact, the second ring waveform support 1 and interface 14 are all located at the overlay film place of main body 17 On tube wall.

In the present embodiment, arch of aorta art medium-height trestle includes main body 17 and the first branch 5, the second branch 6 and the 3rd Branch 7, main body 17 and these three branches all in tubular construction, including metallic support and the overlay film wrapping this metallic support 25, and the first branch 5, the second branch 6 and the 3rd branch 7 it is axially axially vertical with main body 17 in a free state.Please join Read Fig. 2, schematic diagram after the completion of aortic arch release for the arch of aorta art medium-height trestle, wherein main body 17 corresponds to human aortic The sustainer 18 at bow position, the first branch 5, the second branch 6 and the 3rd branch 7 correspond to the innominate artery on the arch of aorta respectively 19th, LCC 20, these three branch vessel of left subclavian artery 21.Main body 17 and the first branch 5, the second branch 6 and The diameter of the 3rd branch 7 is mated with corresponding vessel diameter respectively, a diameter of 32mm of the near-end 22 of such as main body 17, far-end 23 A diameter of 32mm, the first branch 5, the second branch 6 and the 3rd branch 7 all in straight-tube shape, diameter be respectively 18mm, 14mm and 14mm.

In order to clearly show the metal base portion of arch of aorta art medium-height trestle, some figures do not show overlay film.Refer to Metallic support in Fig. 1, Fig. 3, Fig. 8, main body 17 and three branches is respectively by the ring waveform support edge of multi-turn equal diameters Axially spaced rearrange, ring waveform support is formed using the braiding of elastic nitinol alloy wire, the ring-type in main body 17 Waveform support is formed from the titanium-nickel wire braiding of 0.55mm diameter, and the in the first branch 5, the second branch 6 and the 3rd branch 7 Three ring waveform supports 33 are formed from the titanium-nickel wire braiding of 0.4mm diameter.Wherein main body 17 include bend section 171 and with bow portion The fall principal piece 172 that section 171 is connected, described bow section 171 includes three the second ring waveform supports 1,2,3, is respectively used to support First branch 5, the second branch 6 and the 3rd branch 7.This three the first ring waveform supports 1,2,3 are independent of each other, and point Not Wei Yu the first branch 5, the second branch 6 and the 3rd branch 7 first end a lower section.Preferably, in order to ensure three branches it Between distance can adjust, there is no connecting rod between these three second ring waveform supports 1,2,3, but be close to common overlay film Organize integral on 25, such branch can according to the distance between branch vessel adjust automatically relative position.

The fall principal piece 172 of main body 17 adopts first even near far-end 23, the first ring waveform support 31 of this fall principal piece 172 Extension bar 9 links together, and described head rod 9 is linear elastic yarn.First branch 5, the second branch 6 and the 3rd branch 7 metallic support is all made up of using connecting rod three circle the 3rd ring waveform supports 33, and passes through one second respectively even The second ring waveform support 1 in extension bar 10 and main body 17, the second ring waveform support 2 or the second ring waveform support 3 are formed Man-to-man connection, the second connecting rod 10 is L-shaped elastic yarn.Each branch also can be long-armed next by the second connecting rod 10 Connect the multiple 3rd ring waveform supports 33 in branch, then by corresponding in main body one of the galianconism of the second connecting rod 10 Second ring waveform support connects.The support force that main body 17 provides to branch, the second connecting rod 10 so can be improved further The side of the near-end 22 towards main body 17 in the branch that can be arranged on, both can allow branch to be compressed and be partial to main body 17 Far-end 23 moreover it is possible to ensure that branch returns to the position substantially vertical with main body 17, prevent branch from excessively tilting to far-end 23 and not The risk that can set back.

In order to branch and main body 17 angle can moderate change, to adapt to the vascular morphology of different patients it is preferable that leaning on 3rd ring waveform support 33 described in the one of described first end a of closely each described branch and the distance between described main body 17 L4 Scope be 4mm-10mm, that is, minimum range L4 of the metallic support of the lowermost end of each branch and main body is 4-10mm, with this To select the length of the second connecting rod 10.Generally, the support force that the 3rd branch 7 needs is more than the first branch 5 and institute of the second branch 6 The support force needing, the second connecting rod 10 of the 3rd branch 7 can make of thicker or harder material, and the first branch 5 and second Second connecting rod 10 of branch 6 can make of slightly thin or softer material.

Preferably, the second ring waveform support 1 to the first branch 5 is closer to the near-end 22 of main body 17, and the of the first branch 5 Two connecting rods 10 are positioned close to near-end 22 side of main body 17, are conducive to positioning in branch vessel for first branch 5.In order to Main body 17 distribution substantially uniform to the support force of each branch is it is preferable that the second ring waveform support 2 to the second branch 6 more leans on Nearly first branch 5, the second ring waveform support 3 to the three branch 7 is closer to the second branch 6.

In order to strengthen the adherence quality of branch, in the described 3rd ring waveform support 33 of each described bifurcation, close The height minimum of the waveform of one described 3rd ring waveform support 33 of described second end b of this branch and the quantity of this waveform At most, that is, the waveform arrangement of the 3rd ring waveform support 33 on branch top is more intensive；Taking the first branch 5 as a example, refer to Fig. 4, the waveform number of first lap the 3rd ring waveform support 33 positioned at top is nine, and remaining two circle the 3rd ring waveform props up The waveform number of frame 33 is six.

The bottom of the overlay film 25 of each branch is connected on the overlay film 25 of main body 17 side wall, and the overlay film 25 in main body 17 One interface of upper formation（14、15、16）, the inner chamber of main body 17 communicated with the inner chamber of branch by this interface.Refer to Fig. 5, The top view of the first branch 5, a waveform 8 of the second ring waveform support 1 just bypasses one on the overlay film 25 of main body 17 Circular interface 14, the side wall overlay film 25 of main body 17 is continuously integral around interface 14 with the overlay film 25 of the first branch 5, That is, this interface 14, both on the side wall of main body 17, also is located at first end a of the first branch 5.Because overlay film 25 has necessarily Thickness and toughness, the pressure to main body 17 for first branch 5, the second ring waveform is delivered to by the overlay film 25 of interface 14 periphery That is to say, that the second ring waveform support 1 provides support force to the first branch 5 on the waveform 8 of support 1.Refer to Fig. 5, in order to Increase the supporting role to the first branch 5 for the second ring waveform support 1, described closure line of demarcation c embeds described V-type line of demarcation d Depth in area defined is at least 50% with the ratio of the height of this V-type line of demarcation d area defined；Or refer to Fig. 4, interface 14 enter the waveform 8 of the second ring waveform support 1 around region in depth L2 be more than the height L1 of waveform 8 50%.Main body 17 so can be increased to the radial support power of branch so that branch can be by main body 17 after main body 17 is released Safe heads in corresponding branch vessel, and after branch's release, can prevent this branch in corresponding branch vessel Slip out.

Preferably, refer to Fig. 4, the height L1 of the waveform 8 of the second ring waveform support 1 is more than the half of circle interface 14 Footpath, the center of interface 14 also be located at waveform 8 around region in.Preferably, the second ring waveform support 2 and the second branch 6 Relative position meets same condition, and the relative position of the second ring waveform support 3 and the 3rd branch 7 also meets same article Part, to increase the radial support power to each branch.Refer to Fig. 5, one around interface 14 of the second ring waveform support 1 Radius of corner R of waveform 8 is 3mm, and the width L3 after this waveform 8 launches is 25mm；The interface 14 of the first branch 5 is a diameter of 18mm, then the depth that interface 14 embeds within waveform 8 can reach more than the 50% of the height of waveform 8.Similar, the second ring-type Waveform support 2, radius of corner R of a waveform 8 around the corresponding interface 15,16 of the second ring waveform support 3 are 3mm, Width after this two waveforms launch is 20mm, and the second branch 6 and the interface 15 of the 3rd branch 7,16 diameters are 14mm. So design can ensure that the waveform 8 in main body 17 has enough width to accommodate the interface of corresponding branch it is ensured that interface is embedding Enter that the depth within waveform 8 in main body 17 can reach the height of this waveform 8 more than 50%.

After metallic support completes, coating processes are started using overlay film mould 40.The same arch of aorta of overlay film mould 40 Morphosis coupling, be also to be made up of a main part and three components.First operation of overlay film is to make internal layer EPTFE membrane is overlayed on the surface of mould by film first, and inner layer film can be the individual layer ePTFE membrane of thickness 0.03～0.1mm, or The relatively thin ePTFE membrane of multilayer is folded into condition of equivalent thickness, completes internal layer membrane process.

Second operation is that the metallic support completing braiding is enclosed within the die surface covering inner layer film.Specifically, please Refering to Fig. 6, by the metallic support on the second ring waveform support 1 and the first branch 5, the second ring waveform support 2 and second point Near far-end 23 in metallic support in metallic support on 6, the second ring waveform support 3 and the 3rd branch 7, main body 17 Other ring waveform supports are individually placed to the position shown in Fig. 6.Preferably, each branch of mould embeds the second ring in main body The depth within waveform 8 of shape waveform support exceedes the 50% of the height of this waveform 8.

3rd operation is outer layer membrane process, covers ePTFE membrane again in metallic support outer surface, and metallic support is overall（Bag Include the metallic support of main body 17 and three branches）Cladding is got up completely.Outer membrane can be the individual layer of thickness 0.03～0.1mm EPTFE membrane, or the relatively thin ePTFE membrane of multilayer is folded into condition of equivalent thickness.The region directly fitted in inner layer film and outer membrane, covers The gross thickness of film 25 is 0.06～0.2mm.After the completion of three above operation, by applying stressed mode in high temperature, will be interior Layer and outer layer ePTFE overlay film fit together, and metallic support is fixed on the centre of overlay film 25, by whole support after the completion of this operation Pull down from mould, ePTFE membrane unnecessary for two ends in main body 17 is cut, form near-end 22 and far-end 23, finally as Fig. 7 institute Show.Preferably, the distance of first end a of near-end 22 to the first branch 5 of the overlay film 25 in main body 17 is 5-10mm.

After the completion of ePTFE overlay film, also optional step：Suture near-end fabric 12 or far-end fabric in main body 17 13, the two can be woven dacron.Refer to Fig. 8, the near-end 22 for the ease of the main body 17 of arch of aorta art medium-height trestle and blood The suture of pipe, after the completion of overlay film, sutures the woven dacron of tubulose, i.e. near-end fabric 12, described woven dacron in the near-end 22 of main body 17 Fixing end be stitched together near the second ring waveform support 1 of near-end 22, the free end of woven dacron is to the first branch 5 Distance is 25-35mm, preferably 30mm.Near-end fabric 12 is divided into first paragraph 121 and second segment 122, and first paragraph 121 does not comprise metal Support, does not have metallic support to support in it, have metallic support to support, second segment 122 in the pipe that the woven dacron of second segment 122 surrounds Can be overlapping with the second ring waveform support 1 and be stitched together.A diameter of 29mm of the tubulose woven dacron in first paragraph 121, than The diameter of main body 17 is smaller；Because the diameter of the free state of main body 17 can be more bigger than the aorta diameter of aortic arch, and The free end diameter of Dacron pipe should be equal with blood vessel diameter, in order to avoid during vascular suture, terylene is furnished with fold, so Dacron pipe Free end diameter more smaller than the diameter of main body 17 near-end 22.And the tubulose woven dacron in second segment 122 is a diameter of 32mm is identical with the diameter of main body 17.

In addition, the far-end 23 in main body 17 sutures far-end fabric 13, Fig. 8 illustrates the woven dacron of far-end fabric 13 in far-end 23 The first kind of way of arrangement, this woven dacron is overlapping with last lap the first ring waveform support 31 of the fall principal piece 172 of main body 17 And be stitched together.After the completion of far-end fabric 13 is fixing, so can ensure that the far-end 23 of main body 17 also has good suture Performance, provides condition for possible surgical operation at a specified future date.If far-end fabric 13 is just alignd with main body 17 far-end 23, at a specified future date The suture of surgical operation is stitched together with far-end fabric 13 and main body 17 far-end 23.Fig. 9 illustrates the second of far-end fabric 13 Embodiment, is divided into two regions, respectively first area 131 and second in the far-end fabric 13 of far-end 23 suture of main body 17 Region 132.The fixing position of the woven dacron of first area 131 last three circle first ring-type ripples with the fall principal piece 172 of main body 17 Shape support 31 is overlapping and is stitched together, and the woven dacron of second area 132 has free end and stretches out the far-end 23 1 of main body 17 Segment distance, length is 8-12mm, preferably 10mm, and second area 132 does not comprise metallic support, does not have in main body 17 in it First ring waveform support 31 supports.After the completion of there is far-end fabric 13 fixation of free end, so can ensure that main body 17 Far-end 23 also has more easily sewing properties, the second area 132 of far-end fabric 13 stretch out main body 17 far-end 23 certain away from From then the suture of surgical operation at a specified future date can be stitched together with the woven dacron of the second area 132 stretching out main body 17 far-end 23.

Refer to Figure 10, the master that the arch of aorta art medium-height trestle that second embodiment of the invention provides is provided with first embodiment Arch of aorta art medium-height trestle is roughly the same, and unlike first embodiment：Described second end b near each described branch The diameter of one described 3rd ring waveform support 33 along this branch described first end a to described second end b direction gradually Reduce and make the overlay film at the described second end b of this branch have conical pipe wall, that is, this portion is in shrink mouth shape.For example it is located at first point Upper end diameter D1 propping up the 3rd ring waveform support 33 of 5 tops is 16mm, and lower end diameter D2 is 18mm, i.e. upper end diameter D1 Less 2mm than lower end diameter D2, and other two circle the 3rd ring waveform supports 33 are Straights, its a diameter of 18mm.Second point The structure propped up in the 6, the 3rd branch 7 is identical with the first branch 5, is all that top one encloses the 3rd ring-type ripple support for taper necking Shape designs, the top diameter 2mm less than lower end diameter.This design can ensure that the 3rd ring waveform is enclosed in each branch lower end two Support 33 and branch vessel are fully contacted, and provide enough radial supports, and circle the 3rd ring waveform being simultaneously located at top props up The top of frame will not have very big expansionary force to branch vessel, reduces the damage to blood vessel with this.

Refer to Figure 11, the master that the arch of aorta art medium-height trestle that third embodiment of the invention provides is provided with first embodiment Arch of aorta art medium-height trestle is roughly the same, and unlike first embodiment：Near described first end a of each described branch one The diameter of individual described 3rd ring waveform support 33 gradually subtracts along the described second end b of this branch to the direction of described first end a Overlay film at described first end a of little Er Shigai branch has conical pipe wall, and that is, this portion is in shrink mouth shape.For example it is located at the first branch Upper end diameter D2 of the 3rd ring waveform support 33 of 5 lowermost ends is 18mm, and lower end diameter D1 is 16mm, i.e. upper end diameter D2 Bigger 2mm than lower end diameter D1.Structure in second branch 6, the 3rd branch 7 is identical with the first branch 5, the 3rd ring-type of lower end Waveform support 33 is all upper end diameter 2mm bigger than lower end diameter, and this design can ensure that three branch's energy in surgical procedure Enough preferably freely swung, thus preferably adapting to different branch vessel anatomic forms on the arch of aorta.

Additionally, the diameter of all described first ring waveform supports 31 is the direction toward described far-end 23 in described near-end 22 On successively decrease, that is, the reduced diameter of the first ring waveform support 31 in main body 17, is integrally formed a taper, leans on That first ring waveform support 31 diameter D4 of nearly second ring waveform support 3 be 32mm, positioned at distalmost end that first The diameter D3 of ring waveform support 31 is 28mm；In main body 17, this section using taper design is to put in descending aorta, and Human body descending aorta internal diameter is also diminishing, therefore can preferably adapt to the anatomic form of descending aorta.

It is to be appreciated that as the optimization design in this programme, near one of the described second end b of each described branch The diameter of described 3rd ring waveform support 33 is gradually reduced along described first end a of this branch to the direction of described second end b And make the described second end b portion of this branch in shrink mouth shape；Near described first end a of each described branch one the described 3rd The diameter of ring waveform support 33 is gradually reduced along the direction of described second end b extremely described first end a of this branch and makes this point The described first end a portion propped up is in shrink mouth shape.I.e. the both ends of branch all can be designed for shrink mouth shape.In the lowermost end of branch one Enclose the 3rd ring waveform support 33 to design for shrink mouth shape, the diameter near main body 17 side is minimum；In the top of branch one Enclose the 3rd ring waveform support 33 to design for shrink mouth shape, the diameter of top side is minimum.

Refer to Figure 12, the master that the arch of aorta art medium-height trestle that fourth embodiment of the invention provides is provided with first embodiment Arch of aorta art medium-height trestle is roughly the same, and unlike first embodiment：Connect between all described first ring waveform supports 31 It is connected to head rod 9, described head rod 9 is linear elastic yarn；Described arch of aorta art medium-height trestle also includes one Second connecting rod 10, described second connecting rod 10 is L-shaped elastic yarn, and the galianconism of described second connecting rod 10 is fixed on described On head rod 9, the long-armed connection of described second connecting rod 10 is to and described fall principal piece 172 between described in closest one On all described 3rd ring waveform support 33 in branch.I.e. the first branch 5, the second branch 6, the metal in the 3rd branch 7 Only linked together by overlay film 25 between support and the second ring waveform support 1,2,3 in main body 17 but not over being connected Bar connects, and does not also have connecting rod between the second ring waveform support 1,2,3.Further, prop up in described arch of aorta art Frame also includes the 3rd connecting rod 11, and remaining branch in addition to the described branch being connected with described second connecting rod 10 is all connected with There is the 3rd connecting rod 11 described in, each described 3rd connecting rod 11 is linear elastic yarn.The tubulose overlay film of each branch 25 bottom is separately fixed on the overlay film 25 of main body 17, and these overlay films 25 continuously become an entirety and have certain thickness and tough Property, therefore, the second ring waveform support 1,2,3 provides sufficient support force to three branches by this overall overlay film 25.And And, there is no the restriction of connecting rod it is allowed to each branch does with respect to main body 17 between the second ring waveform support 1,2,3 and branch Angle by a small margin or the adjustment of distance, to adapt to the otherness of the vascular morphology structure of different patients.

The first ring waveform support 31 in main body 17 is linked together using connecting rod, forms arch of aorta art medium-height trestle Fall principal piece 172.Due in operation technique it is necessary to first the fall principal piece 172 of arch of aorta art medium-height trestle and the 3rd branch 7 be released Put and be positioned at corresponding Ink vessel transfusing, the positioning of the 3rd branch 7 is difficulty highest in three branches, therefore by the 3rd branch 7 Metallic support linked together by second connecting rod 10 with above-mentioned fall principal piece 172, the second connecting rod 10 is L-shaped Elastic yarn.It is provided with head rod 9, described head rod 9 is in straight between all described first ring waveform supports 31 The elastic yarn of line.Preferably, head rod 9 is arranged on the side of the close branch of fall principal piece 172.Second connecting rod 10 is permissible It is directly anchored on a first ring waveform support 31 of fall principal piece 172, but need not be connected with head rod 9.

The second connecting rod 10 in the present embodiment is located at the far-end 23 1 of the close arch of aorta art medium-height trestle of the 3rd branch 7 Side, to constrain the angle between the 3rd branch 7 and described fall principal piece 172, such 3rd branch 7 can rely on second after being released The screen resilience of connecting rod 10 is directed at the direction of corresponding branch vessel.This second connecting rod 10 can also be used for connecting the 3rd branch 7 On the 3rd ring waveform support 33 be fixed to the fall master of arch of aorta art medium-height trestle it is preferable that this second connecting rod 10 extends On the head rod 9 of section 172, stablize the angle between this fall principal piece 172 and the 3rd branch 7 further, and by main body 17 The extra radial support power that provided of fall principal piece 172 the 3rd branch 7 is headed in branch vessel.Arch of aorta art medium-height trestle Fall principal piece 172 and the 3rd branch 7 between stable support and positioning, also help the first branch 5 and the release of the second branch 6 And positioning, also allow the first branch 5 and the second branch 6 respectively according to vascular morphology come adjustment angle and distance.Alternatively, first Connecting rod 9 and the second connecting rod 10 can make of same elastic yarn.

In the arch of aorta art that the arch of aorta art medium-height trestle that fifth embodiment of the invention provides is provided with first embodiment Support is roughly the same, and unlike first embodiment：Overlay film in arch of aorta art medium-height trestle integrally selects terylene cloth material, Replace the ePTFE membrane in embodiment one；Woven dacron is centered around respectively the appearance of the metallic support of main body 17 and three branches Face or inner surface, are then stitched together with metallic support by suture.Similar to the Fig. 9 in embodiment one, in main body 17 near-end 22, terylene is furnished with long 25-35mm（Preferably 30mm）Region does not have ring waveform support to support, and diameter compares main body 17 remainder diameter is smaller；In the far-end 23 of main body 17, terylene is furnished with long 8-12mm（Preferably 10mm）Region there is no ring Shape waveform support supports, diameter and main body 17 have ring waveform support section diameter identical.

Refer to Figure 14, the arch of aorta art medium-height trestle manufacture method that first embodiment of the invention provides, walk including following Suddenly：

S1）Refer to Figure 13, an overlay film mould 40 is provided, overlay film mould 40 mates with the morphosis of the arch of aorta.Institute State overlay film mould 40 to include the first cylinder 41 and be connected to the second cylinder 42 on described first cylinder 41, described first cylinder 41 It is divided into the branch of the first shell of column 411 and the second shell of column 412, the quantity of described second cylinder 42 and described arch of aorta art medium-height trestle Quantity is identical, and described second cylinder 42 is connected on described second shell of column 412.

S2）In the inner layer film of the outer surface described overlay film 25 of making of described overlay film mould 40, ePTFE membrane is overlayed on mould Surface, inner layer film can be the individual layer ePTFE membrane of thickness 0.03～0.1mm, or the relatively thin ePTFE membrane of multilayer is folded on an equal basis Thickness, completes internal layer membrane process.

S3）There is provided some described ring waveform supports, ring waveform support is formed using the braiding of elastic nitinol alloy wire, main Ring waveform support on body 17 is formed from the titanium-nickel wire braiding of 0.55mm diameter, and the first branch 5, the second branch 6 and the Ring waveform support 33 in three branches 7 is formed from the titanium-nickel wire braiding of 0.4mm diameter, several first ring waveforms described Support 31 interval is placed on described first shell of column 411, and each described second ring waveform support is placed on described second shell of column 412 And the side of the close described near-end positioned at described second cylinder 42 corresponding with this second ring waveform support, and make this Wherein one waveform 8 of the second ring waveform support is stuck on this corresponding described second cylinder 42, and described 3rd ring waveform props up Frame 33 interval is placed on every one second cylinder 42, finally as shown in Figure 6.Preferably, each branch of mould embeds in main body The depth within waveform 8 of ring waveform support exceedes the 50% of the height of this waveform 8.

S4）In the outer membrane of the outer surface described overlay film 25 of making of described overlay film mould 40, and make described outer membrane and institute State inner layer film to combine and wrap up described ring waveform support.Cover ePTFE membrane in metallic support outer surface again, metallic support is overall （Metallic support including main body 17 and three branches）Cladding is got up completely.Outer membrane can be the list of thickness 0.03～0.1mm Layer ePTFE membrane, or the relatively thin ePTFE membrane of multilayer is folded into condition of equivalent thickness.The region directly fitted in inner layer film and outer membrane, The gross thickness of overlay film 25 is 0.06～0.2mm.By applying stressed mode in high temperature, by internal layer and outer layer ePTFE overlay film Fit together, metallic support is fixed on the centre of overlay film 25, after the completion of this operation, whole support is pulled down from mould, will lead On body 17, the unnecessary ePTFE membrane in two ends is cut, and forms near-end 22 and far-end 23, finally as shown in Figure 7.Preferably, in main body 17 The distance of the bottom to the first branch 5 for the near-end of overlay film 25 be 5-10mm.

Further, also include step S5）And S6）, wherein step S5）Suture near-end fabric 12 and far-end in main body 17 Fabric 13, both at woven dacron.Refer to Fig. 8, the fixing end of woven dacron and the second ring waveform support 1 near near-end 22 It is stitched together, the distance of free end to first branch 5 of woven dacron is 25-35mm, preferably 30mm.Near-end fabric 12 is divided into It is stitched together completely with the second ring waveform support 1 of near-end 22 with second segment 122, second segment 122 for one section 121.First paragraph A diameter of 29mm of the tubulose woven dacron in 121, more smaller than the diameter of main body 17.And the tubulose woven dacron in second segment 122 A diameter of 32mm is identical with the diameter of main body 17.

Step S6）Fig. 8 illustrates the first kind of way that woven dacron is arranged in far-end 23, sutures far-end in the far-end 23 of main body 17 Fabric 13, far-end fabric 13 is overlapping with last lap the first ring waveform support 31 of the fall principal piece 172 of main body 17 and is sewn to Together.Fig. 9 illustrates the second way that woven dacron is arranged in far-end 23, in 13 points of the far-end fabric of far-end 23 suture of main body 17 For two regions, respectively first area 131 and second area 132.The fixing position of the woven dacron of first area 131 and main body In 17 fall principal piece 172, last three enclose the first ring waveform support 31 overlap and are stitched together, the woven dacron of second area 132 For stretching out far-end 23 1 segment distance of main body 17, length is 8-12mm, preferably 10mm, and second area 132 does not comprise metal Support, does not have the ring waveform support in main body 17 to support in it.

It is to be appreciated that step S5）And S6）Can replace, before and after replacement, effect is the same.

Refer to Figure 15, arch of aorta art medium-height trestle manufacture method and first embodiment that second embodiment of the invention provides The arch of aorta art medium-height trestle manufacture method providing is roughly the same, and unlike first embodiment：Step S2）With S4）.

Wherein step S2）In the sheathed described overlay film 25 of outer surface of described overlay film mould 40, described overlay film 25 is woven dacron.

S4）By suture, described overlay film 25 is stitched together with described ring waveform support, in the near-end of main body 17 22, terylene is furnished with long 25-35mm（Preferably 30mm）Region do not have ring waveform support support, and diameter than main body 17 remaining Section diameter is smaller；In the far-end 23 of main body 17, terylene is furnished with long 8-12mm（Preferably 10mm）Region do not have ring waveform to prop up Frame supports, diameter and main body 17 have ring waveform support section diameter identical.

Refer to Figure 16, arch of aorta art medium-height trestle manufacture method and first embodiment that third embodiment of the invention provides The arch of aorta art medium-height trestle manufacture method providing is roughly the same, and unlike first embodiment：Step S2）、S3）With S4）.

Wherein step S2）There is provided some described ring waveform supports, ring waveform support is compiled using elastic nitinol alloy wire Knit and form, the ring waveform support in main body 17 is formed from the titanium-nickel wire braiding of 0.55mm diameter, and the first branch 5, second Ring waveform support 33 in branch 6 and the 3rd branch 7 is formed from the titanium-nickel wire braiding of 0.4mm diameter, described several the One ring waveform support 31 interval is placed on described first shell of column 411, and each described second ring waveform support is placed on described the On two shell of columns 412 and be located at the close described near-end of described second cylinder 42 corresponding with this second ring waveform support Side, and so that wherein one waveform 8 of this second ring waveform support is stuck on this corresponding described second cylinder 42, the described 3rd Ring waveform support 33 interval is placed on every one second cylinder 42, finally as shown in Figure 6.Preferably, each branch of mould is embedding Enter the ring waveform support in main body the depth within waveform 8 exceed this waveform 8 height 50%.

S3）In the sheathed described overlay film 25 of outer surface of described ring waveform support, described overlay film 25 is woven dacron.

The arch of aorta art medium-height trestle that the present invention provides can adapt to the blood vessel near the arch of aorta of different patients automatically Main body in structure, and arch of aorta art medium-height trestle keeps enough radial support power to branch it is ensured that in operation actively Branch on arcus haemalis art medium-height trestle be capable of safety enter in branch vessel, simultaneously in operation and postoperative avoid branch from Slip out in corresponding branch vessel.The arch of aorta art medium-height trestle that the present invention provides has advantages below：

3）Heretofore described arch of aorta art medium-height trestle, main body and branch can be using overall ectonexines EPTFE membrane bilayer film coating technique, the inner wall smooth of branch, reduce the formation of thrombus, cerebral vessels are formed with good protection Effect.Between branch and main body, no suture is connected, no the risk of blood leakage.Can in main body additional near-end fabric, for example, It is sewed with the woven dacron of one section of tubulose in the near-end of main body, this section of some region of woven dacron near-end does not have metallic support to support, And this part of woven dacron diameter is slightly less than main body has metallic support to bend the diameter of section part, and woven dacron ensure that and blood vessel Reliably it coincide, the smaller appearance that turn avoid with woven dacron fold during vascular anastomosis of its diameter.Additionally, main body can also be added Far-end fabric, for example, the far-end seam of main body can also be sewed with the woven dacron of one section of tubulose, and the far-end of this section of woven dacron is a bit of Region also can be without metallic support and supports, and this section of woven dacron ensure that the far-end of main body has reliable sewing properties, for remote Phase possible surgical treatment provides guarantee.

The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all essences in the present invention Any modification, equivalent and improvement made within god and principle etc., should be included within the scope of the present invention.

Claims

1. a kind of arch of aorta art medium-height trestle, has elasticity and can be compressed, including main body in a tubular form and one to three be in The branch of tubulose, has, on the tube wall of described main body and on the tube wall of described branch, the overlay film being connected, described main body Proximally and distally respectively there is one first opening, described main body includes bending section and fall principal piece, and described branch is all arranged in bow section The same side, the same side of described bow section has and first end with each described branch equal with the quantity of described branch even The interface connecing, each described interface formed on described overlay film one closure line of demarcation, each described branch with its first end The second relative end there is one second opening it is characterised in that：Described fall principal piece includes at least one first ring waveform support, Described bow section includes the second ring waveform support equal with the quantity of described branch, and each described branch includes at least one 3rd ring waveform support, branches into the first branch from described in nearest one of near-end of described arch of aorta art medium-height trestle, Part bow section between described near-end and described first branch includes a second ring waveform support, and described overlay film is by institute The described first ring waveform support, described second ring waveform support and the described 3rd ring waveform support that have connect into one Body；

In at least one described branch arrange a second L-shaped connecting rod, described second connecting rod long-armed by this branch On multiple described 3rd ring waveform support link together, the galianconism of described second connecting rod is fixed on described in support one On second ring waveform support of branch；

Or, at least one described branch arranges a second L-shaped connecting rod, described the long-armed of second connecting rod should Multiple described 3rd ring waveform support in branch links together, and described fall principal piece includes the axially spaced-apart along described main body Multiple first ring waveform supports of arrangement, are connected with head rod between the plurality of first ring waveform support, described The galianconism of the second connecting rod is fixed on described head rod；

Or, at least one described branch arranges linear 3rd connecting rod, described 3rd connecting rod is by this branch On multiple described 3rd ring waveform support link together.

2. arch of aorta art medium-height trestle as claimed in claim 1 it is characterised in that：Described head rod be linear pattern and with Described branch is in the same side of described main body.

3. arch of aorta art medium-height trestle as claimed in claim 2 it is characterised in that：All described first ring waveform supports Diameter is equal or successively decreases on the direction of described near-end to described far-end.

4. arch of aorta art medium-height trestle as claimed in claim 2 it is characterised in that：From described in described fall nearest one of principal piece Branch includes spaced multiple 3rd ring waveform support, close in a described branch nearest from described fall principal piece The side of described fall principal piece arranges a second L-shaped connecting rod, and the long-armed of described second connecting rod will be from described fall principal piece Multiple 3rd ring waveform supports in a nearest described branch link together, and the galianconism of described second connecting rod is fixed On described head rod or on a first ring waveform support of a nearest described branch of described fall principal piece.

5. arch of aorta art medium-height trestle as claimed in claim 1 it is characterised in that：Each described branch is respectively described in one The second ring waveform support supported, institute corresponding to around respective branch for the waveform on this second ring waveform support State closure line of demarcation.

6. arch of aorta art medium-height trestle as claimed in claim 5 it is characterised in that：Each described branch includes spaced Multiple 3rd ring waveform supports, described second connecting rod is located at the side of the near-end of close described main body of described branch.

7. arch of aorta art medium-height trestle as claimed in claim 5 it is characterised in that：Described waveform is in described closure point accordingly Form V-type line of demarcation, described closure line of demarcation embeds in the area defined of described V-type line of demarcation on the overlay film of the surrounding in boundary line That a part of depth be at least 1 with the ratio of the height of this V-type line of demarcation area defined:2, or, described closure point At least half area in boundary line is located in the area defined of described V-type line of demarcation.

8. arch of aorta art medium-height trestle as claimed in claim 6 it is characterised in that：Near each described branch described first The 3rd ring waveform support described in one at end is 4mm-10mm with the distance between described bow section scope.

9. arch of aorta art medium-height trestle as claimed in claim 6 it is characterised in that：In each described bifurcation the described 3rd In ring waveform support, the height of the waveform of a described 3rd ring waveform support at described second end of this branch close is Little and this waveform quantity is most.

10. arch of aorta art medium-height trestle as claimed in claim 6 it is characterised in that：Near each described branch described the The diameter of one described 3rd ring waveform support at two ends along this branch described first end to described second end direction by The described the second end of decrescence little Er Shigai branch is in shrink mouth shape.

11. arch of aorta art medium-height trestles as claimed in claim 6 it is characterised in that：Near each described branch described the The diameter of one described 3rd ring waveform support of one end along this branch described second end to described first end direction by The described first end of decrescence little Er Shigai branch is in shrink mouth shape.

12. arch of aorta art medium-height trestles as claimed in claim 1 it is characterised in that：The material of described overlay film is varicosity poly- four PVF, described overlay film includes inner layer film and outer membrane, and described inner layer film and outer membrane combine with by all described ring waveforms Support is wrapped between inner layer film and outer membrane.

13. arch of aorta art medium-height trestles as claimed in claim 1 it is characterised in that：The material of described overlay film is woven dacron, institute Described ring waveform support is had to be sewn to the outside of tube wall or the inner side of described overlay film.

14. arch of aorta art medium-height trestles as claimed in claim 1 it is characterised in that：In described near-end and described first branch Between a part bow section only one of which the second ring waveform support, between two neighboring branch each section bow section Also only one of which the second ring waveform support.

15. arch of aorta art medium-height trestles as in any one of the preceding claims it is characterised in that：The near-end of described main body sets It is equipped with near-end fabric in a tubular form, described near-end fabric is connected with described overlay film, the first paragraph of described near-end fabric and institute State the second ring waveform support to separate, the second segment of described near-end fabric is fixed on described second ring waveform support, described The diameter of the second segment than described near-end fabric for the diameter of the first paragraph of near-end fabric is little；The far-end of described main body is provided with pipe The far-end fabric of shape, described far-end fabric is connected with described overlay film, and is fixed on described first ring waveform support, institute State far-end fabric to align with the end face of described far-end or outside described far-end fabric stretches out described far-end.

A kind of 16. manufacture methods of arch of aorta art medium-height trestle as claimed in claim 1, comprise the steps：

S1) provide an overlay film mould, described overlay film mould includes the first cylinder and is connected to the second post on described first cylinder Body, described first cylinder is divided into the first shell of column and the second shell of column, props up in the quantity of described second cylinder and described arch of aorta art The numbers of branches of frame is identical, and described second cylinder is connected on the same side of described second shell of column；

S2) outer surface in described overlay film mould makes the inner layer film of described overlay film；

S3 some ring waveform supports) are provided, described ring waveform support is the first ring waveform support, the second ring waveform props up Frame and the 3rd ring waveform support, all first ring waveform spacer support frames are placed on described first shell of column, and each described second Ring waveform support is placed on described second shell of column and is spaced apart described second cylinder, at least one second ring waveform support Between the near-end and the second cylinder of the first cylinder, each second cylinder mates at least one second ring waveform support, And so that wherein one waveform of this second ring waveform support is stuck on corresponding described second cylinder of this second ring waveform support, Described 3rd ring waveform spacer support frame is placed on every one second cylinder；

S4) described ring waveform support is sewn on described inner layer film, using inner layer film as overlay film；Or, cover in described The outer surface of film die makes the outer membrane of described overlay film, and so that described outer membrane is combined with described inner layer film and wrap up described ring Shape waveform support.

A kind of 17. manufacture methods of arch of aorta art medium-height trestle as claimed in claim 1, comprise the steps：

S2 some ring waveform supports) are provided, described ring waveform support is the first ring waveform support, the second ring waveform props up Frame and the 3rd ring waveform support, all first ring waveform spacer support frames are placed on described first shell of column, and each described second Ring waveform support is placed on described second shell of column and is spaced apart described second cylinder, at least one second ring waveform support Between the near-end and the second cylinder of the first cylinder, each second cylinder mates at least one second ring waveform support, And so that wherein one waveform of this second ring waveform support is stuck on corresponding described second cylinder of this second ring waveform support, Described 3rd ring waveform spacer support frame is placed on every one second cylinder；

S3) in the sheathed described overlay film of outer surface of described ring waveform support；

S4) by described overlay film and described ring waveform support suture.

The manufacture method of 18. arch of aorta art medium-height trestles as described in claim 16 or 17 it is characterised in that：Also include as follows Step：

S5) near described near-end a described second ring waveform support be arranged at covering on this second ring waveform support Film suture a near-end fabric in a tubular form, described near-end fabric have with this detached first paragraph of the second ring waveform support and The second segment suturing with this second ring waveform support, the diameter of described first paragraph is less than the diameter of described second segment；

S6) at least a portion the first ring waveform support in some described first ring waveform supports be arranged at these first The overlay film of ring waveform support sutures a far-end fabric in a tubular form, described far-end fabric align with the end face of described far-end or Described far-end fabric stretches out outside described far-end.